All About Drugs

Tout sur les médicaments הכל על תרופות كل شيئ عن الأدوية Все о наркотиках 关于药品的一切 డ్రగ్స్ గురించి అన్ని 마약에 관한 모든 것 Όλα για τα Ναρκωτικά Complete Tracking of Drugs Across the World by Dr Anthony Melvin Crasto, Worldpeacepeaker, worlddrugtracker, PH.D (ICT), MUMBAI, INDIA, Worlddrugtracker, Helping millions, 9 million hits on google on all websites, 2.5 lakh connections on all networks, “ALL FOR DRUGS” CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This is a compilation for educational purposes only. P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent

Isolation and identification of antibiotic albaflavenone from Dictyophora indusiata

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Jul 162013

Isolation and identification of antibiotic albaflavenone from Dictyophora indusiata

Dictyophora indusiata is a stinkhorn fungus growing in bamboo thickets which has been used as ingredient in Chinese traditional foods for a very long time due to it delicious taste and high nutritional value. It has become a popular ingredient in Chinese cuisine because advances in its cultivation since 1979 have made it cheap and easily available. It has been observed that the broth could stay unspoiled for several days if D. indusiata were added. It has been widely recognised in Chinese folk medicine that D.indusiata has beneficial effects on some diseases, such as cough, inflammation, diarrhoea and bacterial enteritis. The chemical components and antibacterial activity of extracts of D. indusiata have been reported previously, but the components which have antibacterial activity are still unknown.

http://www.sciencereviews2000.co.uk/blog/view/journal-of-chemical-research/58/isolation-and-identification-of-antibiotic-albaflavenone-from-dictyophora-indusiata/544

Top 10 Drug Giants Scramble For A Piece of China

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Jul 162013

People’s Republic of China

中华人民共和国
Zhōnghuá Rénmín Gònghéguó


	National Emblem

Anthem:

《义勇军进行曲》
Yìyǒngjūn Jìnxíngqǔ (Pinyin)
“March of the Volunteers“

Area controlled by the People’s Republic of China shown in dark green; claimed but uncontrolled regions shown in light green.

With China’s healthcare reform, aging population and growing wealth offsetting concerns over regulatory challenges and intellectual property (IP) protection, the pharmaceutical industry’s center of gravity is shifting east.

There are plenty of opportunities to profit in China. Growth in developed markets, where drug companies make most of their sales, is slowing. The blockbusters of a few years ago are losing patent protection. R.& D. is cheaper in emerging markets like India and China.

China will become the second-biggest pharmaceuticals market in the world by 2020. Most of the top 20 multinational pharmaceutical companies have been expanding their footprint in the research, OTC, distribution, and biotech and are setting up more R&D facilities through various enterprise structures. By investing in China, drug companies like Merck and Novartis are establishing bridgeheads in an important market.

Merck & Co.

Investment: $1.5 billion over 5 years
Themes: Vaccines, diabetes and joint ventures

Merck & Co Inc will establish a new Asian R&D headquarters in Beijing and commit $1.5 billion to research and development in China over the next five years.The No. 2 U.S. drugmaker will eventually employ 600 scientists at its facility, making Merck the latest foreign pharmaceutical company to bolster its presence in China. In addition to research, Merck plans to use its new facility to help it bring existing drugs to the Chinese market. Merck has signed a deal this year with China’s Simcere Pharmaceutical Group (www.simcere.com); aiming to lower costs and allow the company to be in a better position to penetrate the Chinese markets. The company plans to launch new products in China, including medicines for diabetes, infectious diseases and women’s health.

Novartis

Investment: $1.25 billion over 5 years
Themes: R&D and APIs

On Nov. 3, 2009, the Swiss pharmaceutical giant Novartis announced it plans to invest $1.25 billion in a pair of Chinese R&D centers over the next five years. Novartis will put $250 million into a new R&D center and manufacturing facility in Changshu, a city near Shanghai, and another $1 billion to add 1,000 researchers at an existing center in Shanghai. Earlier this year, Novartis received regulatory approval in China from the State Food and Drug Administration (SFDA) for Lucentis® (ranibizumab) to treat wet (neovascular) age-related macular degeneration (AMD), and Galvus® (vildagliptin), an oral treatment for patients with type 2 diabetes approved in China as an add-on to metformin, the standard of care.

In 2011 Novartis acquired Chinese pharmaceuticals and vaccines company Zhejiang Tianyuan Bio-Pharmaceutical (www.ty-pharm.com) for $125 millioin, in a move to expand vaccines presence in China

Roche

Investment: $410 million over several years
Themes: R&D and diagnostics

AstraZeneca

Investment: $200 million
Themes: Branded generics and CRO collaboration

UK-based AstraZeneca announced in 2011 a $200 million investment in a new manufacturing facility in Taizhou in Jiangsu province, set to be completed by the end of 2014. The factory will make AstraZeneca’s own branded drugs as well as generic copies of other medicines. Like other international drugmakers, AstraZeneca is pushing hard into emerging markets as it is seeing a string of lucrative patents running out over the next few years, including Nexium, its $5 billion-a-year blockbuster, and Seroquel(patent expired on march, 2012), its best-selling bipolar drug.

In September 2012, AstraZeneca inked a deal with WuXi PharmaTech (www.wuxiapptec.com) to develop and commercialize MEDI5117, a biologic for rheumatoid arthritis and other inflammatory diseases. Last month, AZ inked a multiyear deal with Chinese CRO Pharmaron(www.pharmaron.com). The partnership will target treatments for cancer and cardiovascular, respiratory, gastrointestinal and infectious diseases. AstraZeneca plans to boost efforts to bring new, innovative drugs to China by hiring 1,000 more people–across R&D, operations and commercial–by 2015.

In December 2011, AstraZeneca acquired Chinese generic injectables maker Guangdong BeiKang Pharmaceutical for an undisclosed sum.

Merck Serono

Investment: $200 million over several years
Themes: R&D and CRO collaboration

Merck Serono, a division of the German giant pharmaceutical company Merck (Merck KgaA), invested $200 million to build and run the Beijing R&D hub on the Pharmaron campus in Beijing.

Pfizer

Investment: $145 million
Themes: Branded generics and joint ventures

Pfizer reported this year in a planned joint venture with Chinese drug firm Zhejiang Hisun Pharmaceutical (www.hisunpharm.com) to manufacture and sell off-patent drugs in China and the rest of the world. Hisun’s expertise in the production of active pharmaceutical ingredients (API), and the fact that Chinese law and regulations favor drugs manufactured in China, will all benefit Pfizer. Registered capital is $250 million and new factories are in Fuyang and Zhejiang provinces. Hisun owns a 51% stake in the venture, while Pfizer is entitled to the remaining stake. Hisun-Pfizer Pharmaceuticals aims to employ 1,000 people by next month.An additional 500 people will be hired in 2013.

Novo Nordisk

Investment: $100 million
Themes: Diabetes

The Chinese diabetes drug market will climb to $2.8 billion by 2015 from $642 million in 2009 while the latest study shows one in 10 people in China have diabetes.

The Danish company Novo Nordisk, the world’s biggest maker of insulin, saw its share of synthetic insulin in china dropped from about 70 percent in 2006 to 53 percent last year after Paris-based Sanofi introduced its 24-hour insulin Lantus in 2004. Novo Nordisk will spend $100 million on research in China to preserve its dominance in the world’s largest market to fend off sanofi as it will train 10,500 doctors and experts in diabetes care. Novo has allocated $40 million for building a research facility in Beijing and $60 million on funding studies and adding 200 scientists in China by 2015.

Sanofi

Investment: $90 million
Themes: Diabetes

The French drugmaker Sanofi-Aventis, the world’s fourth-biggest drug maker, will invest $90 million to boost output of the insulin Lantus in China.

Sanofi-Aventis SA acquired Chinese pharmaceuticals player BMP Sunstone Corp., the maker of the Hao Wa Wa brand of children’s cough and cold treatments, for $520.6 million in October 2010 to expand in Chinese consumer health-care products. Hao Wa Wa, which means Good Baby, is China’s top pediatric cold brand. BMP Sunstone also makes Kang Fu Te brand hygiene products for women.

Eli Lilly

Investment: $80 million, plus undisclosed R&D spend
Themes: Diabetes and branded generics

Lilly, whose antipsychotic drug Zyprexa lost patent exclusivity in October,increased its investment in China generic-drug maker Novast Laboratories Ltd. by $20 million in June 2012 and expanded their collaboration to enhance Lilly’s efforts to offer branded generic medicines in the country. Lilly originally invested in the Novast roughly five years ago through an US$100 million fund run through its venture-capital arm. Novast Laboratories Ltd. makes generic versions of controlled-release and other pharmaceuticals. The company was founded in 2004 and is based in Nantong. Eli Lilly also opened a diabetes R&D center on May 30 in Shanghai with about 150 scientists and staff hired primarily from China.

GlaxoSmithKline

Investment: ~$63 million
Themes: Vaccines and joint ventures

GlaxoSmithKline acquired the remaining 51 percent equity stake in Chinese joint venture Shenzhen Neptunus Interlong Bio-Technique (www.interlong.com) for $39 millio in June 2011, reiterating its dedication to expanding its vaccines offering in greater China.

A Tale of Twin Cancer Drugs – Sorafenib (Nexavar) and Regorafenib (Stivarga)

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Jul 162013

Bayer’s blockbuster hopeful regorafenib, an oral multi-kinase inhibitor and marketed as Stivarga, was approved by the U.S. Food and Drug Administration (FDA) on September 27, 2012 for the treatment of patients with metastatic colorectal cancer (mCRC).

Regorafenib (aka BAY 73-4506, DAST, Fluoro-Sorafenib) has the same chemical structure as the blockbuster cancer therapy Nexavar marketed jointly by Onyx and Bayer, except for the new cancer drug with the substitution of a single fluorine atom in place of a hydrogen atom.

Germany-based Bayer AG and South San Francisco-based Onyx began working together in 1994, and their collaboration on Nexavar brings Onyx all of its revenue.

Nexavar (sorafenib) approved by US FDA against kidney cancer in 2005 and advanced liver cancer in 2007, sells for about $5,000 a month in the United States. Worldwide sales of the drug grew to $481.1 million in the first six months of 2011.

Onyx Pharmaceuticals filed a lawsuit in May 2009, accusing its partner Bayer of trying to cut it out of the collaboration by developing a drug that was almost identical to the their approved cancer drug Nexavar without informing Onyx so it would not have to make royalty payments to Onyx.

The case is Onyx Pharmaceuticals Inc. vs. Bayer Corp., Case No. 3:09-cv-02145 MHP, U.S. District Court, Northern District of California (San Francisco).

Both companies reached an agreement in 2011 with Bayer paying Onyx a one-time $160 million fee plus a royalty of 20% of future regorafenib sales.

Bayer is developing regorafenib as a treatment for gastrointestinal stromal tumors, which mostly occur in the stomach or small intestine. Bayer has applied for FDA approval of the drug for use in patients who have not been helped by treatment with Novartis AG’s drug Gleevec and Pfizer Inc.’s Sutent.

Glybera – The Most Expensive Drug in the world & First Approved Gene Therapy in the West

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Jul 162013

Glybera® (alipogene tiparvovec), the first gene therapy approved in the Western world, is used to treat lipoprotein lipase deficiency (LPLD or familial hyperchylomicronemia), a very rare inherited condition that is associated with increased levels of fat in the blood.

One in a million people have damaged copies of a gene which is essential for breaking down fats. Without lipoprotein lipase (LPL), these patients have significantly increased levels of chylomicrons that carry fat throughout the body. Accumulation of these chylomicrons in the pancreas can lead the the often painful and potentially fatal condition pancreatitis.

Gene therapy using an AAV vector. A new gene is inserted into a cell using the AAV protein shell. The new gene often integrates in a precise location and then makes functional protein to treat a disease.

Alipogene tiparvovec (marketed under the trade name Glybera) is a gene therapytreatment that compensates for lipoprotein lipase deficiency (LPLD), which can cause severe pancreatitis. In July 2012, the European Medicines Agency recommended it for approval, the first recommendation for a gene therapy treatment in either Europe or the United States. The recommendation was endorsed by the European Commission in November 2012 and commercial rollout is expected in late 2013.

http://en.wikipedia.org/wiki/Alipogene_tiparvovec

Glybera, developed by Amsterdam-based UniQure and approved in the European Union in November 2012, is administered only once to be effective but will cost around $1.6 million per patient, a new record for pricey modern medicines. Up to this point in time, Alexion Pharmaceuticals’ orphan drug Soliris, which costs about $410,000/patient/year, has been the most expensive orphan drug in the world. The commerical rollout of Glybera is expected in late 2013.

When an important enzyme is missing, one option is to periodically deliver an exogenously produced replacement, which is what millions of people with diabetes do each day. The other, more permanent option, is to induce one’s own cells to produce the enzyme. Glybera is capable of doing this by encasing the correct LPL gene in an adeno-associated virus (AAV) which hones in on muscle cells. When the AAVs reach their target, they deliver the gene and within a few weeks functional protein is being produced.

The Dutch firm uniQure plans on making Glybera available at specialized medical centers throughout the European Union in summer 2013 and is currently seeking regulatory approval in the US, Canada, and other markets. The company is also developing a raft of other gene therapies to treat diseases including blood clotting disorder haemophilia B, metabolic disorder acute intermittent porphyria, central nervous system disorder Parkinson’s and enzyme disorder Sanfilippo B.

Use of gene therapy has been controversial, and not always successful.

Jesse Gelsinger, an 18-year-old student from Arizona with a mild genetic disorder, had volunteered to participate in a gene therapy trial for the rare genetic disease ornithine transcarbamylase deficiency (OTC) at the University of Pennsylvania in Philadelphia in 1999. He died four days later due to a massive immune response. That failure was followed in 2003 by the development of a leukemia-like disease among two French children treated for ‘bubble baby’ syndrome (X-SCID, severe combined immunodeficiency syndrome) and in 2007 by the death of a woman who received a modified gene in an arthritis trial and

Only two other gene therapies (Gendicine and H101) have previously been approved for sale, both in China. Both have so far shown limited success.

Gendicine (今又生), the first commercialized gene therapy in the world from Shenzhen-based SiBiono in China — Gendicine , the first commercialized gene therapy in the world from Shenzhen-based SiBiono in China

In October 2003, China’s State Food and Drug Administration (SFDA) approved Gendicine , the first commercialized gene therapy in the world from Shenzhen-based SiBion, after the medicine showed some promising results in tumor regression among 99 head and neck squamous cell carcinoma patients. Yet after desperate struggles to expand its market, SiBiono was acquired by NASDAQ-listed Chinese pharmaceutical firm Benda for only US$15 million (£7.6 million).

In November 2005, SFDA approved H101, the world’s first commercialized tumor-killing virus, produced by Shanghai Sunway Biotech . A subtype of gene therapy, H101 (commercially sold as Oncorineis a genetically-modified type-five adenovirus which can selectively replicate inside tumour cells with dysfunctional p53 genes, killing them and stopping the cancer’s spread. Oncorine, which hit the market in November 2006, has also reported a minimal market share.